Master of Pharmacy in Radiopharmacy

Purpose

The objective of this Master of Pharmacy in Radiopharmacy is to train pharmacists with specialised and practical knowledge of Radiopharmacy in the African setting. The qualification aims to provide a broad-based foundation in Radiopharmacy.

The SA Pharmacy Council recognise the discipline of Radiopharmacy as a specialisation. The qualification is a specialisation that leads to registration as a Pharmacist, which requires an appropriate Master's Degree in the relevant field plus two years delivery of the specialist service. According to the SA Pharmacy Council document Specialities for Pharmacists (October 2009), the Radiopharmacist will:

• Perform acts and functions, especially about the profession of a pharmacist as prescribed in the scope of practice of a pharmacist as published in the regulations relating to the practice of pharmacy.
• Take a leading pharmaceutical role in protocol and guideline development in nuclear medicine.
• Act as a leading pharmaceutical partner within a multi-professional health care team in nuclear medicine.
• Develop, implement, evaluate and provide strategic leadership for radiopharmacy services.
• Appraise information, make informed decisions regarding supply and use of radiopharmaceuticals with the evidence available and be able to justify/defend the decisions.
• Develop policies and procedures specifically for the speciality area.
• Develop quality and an evaluative culture within pharmaceutical services.
• Perform pharmaceutical risk management.
• Provide education and training related to radiopharmacy.

Rationale

Radiopharmacy is a specialisation of pharmacy recognised by the South African Pharmacy Council (SAPC) as stipulated in the Pharmacy Act and Regulations. The revised requirements for a Professional Master's Degree in Radiopharmacy for recognition by the SAPC as a specialist Radiopharmacist were published in Board Notice 152 of 2014 on 14 December 2014 in the Government Gazette.

Use radiopharmaceuticals in the diagnosis and treatment of many end-state organ diseases and life-threatening conditions such as major cardiac, renal, endocrine and cerebral disorders, as well as cancers and obscure infections. Their use is growing as they are critical agents in the newer diagnostic modalities such as SPECT-CT and PET scintigraphy. Handle radiopharmaceuticals with care for both safety and efficacy. Their dosage form design, production and manipulation are often highly technical and sensitive to poor handling techniques, which render them ineffective or dangerous. Hence Radiopharmacy is a specialised area which is key to the diagnostic and treatment services offered in Nuclear Medicine.

Radiopharmacy is a scarce skill in South Africa. There is a shortage of specialised radiopharmacy staff in both public and private hospitals. Currently there are only two Council-registered specialist radiopharmacists in South Africa. Also, SA has a thriving radiopharmaceuticals industry, but there is a tremendous shortage of radiopharmacists, with resultant role-substitution. The DTI has invested considerable amounts in the development of a Nuclear Medicine Research Institute (NuMERi) which will need radiopharmacists.

The rationale for the Radiopharmacy Postgraduate qualification is to train radiopharmacists who can register with the SAPC as specialists to ensure safe and effective production and use of radiopharmaceuticals. It is also to provide training for pharmacists throughout Africa, who wish to offer radiopharmacy services in specific settings. Learners would work in tertiary academic hospitals and in private hospitals where there are Nuclear Medicine Departments, as well as in industry.

Recognition of Prior Learning (RPL)

The university does not yet have an RPL policy. All MPharm learners currently undergo interviews as part of the selection process. Their responses regarding previous experience are considered at the interview. No credits are awarded for RPL as the degree is the first of its kind in Africa.

Entry Requirements

The minimum entry requirement for this qualification is

• Bachelor of Pharmacy, NQF Level 8.

This qualification comprises of compulsory and elective topics at Level 9 totalling 240 Credits.

Compulsory Modules, Level 9, 230 Credits

• Pharmaceutical Care, Laboratory Tests and Pharmacokinetics, 6 Credits.
• Radiopharmacology, Radiopharmaceuticals and Radiochemistry, 40 Credits.
• Practice of Radiopharmacy, 38 Credits.
• Medical Physics for Radiopharmacy, 34 Credits.
• Nuclear Medicine for Radiopharmacy, 40 Credits.
• Pharmacy Research Mini Dissertation, 72 Credits.

Elective Topics, Level 10: 10 Credits (Choose/Select one)

• Hospital Radiopharmacy, 10 Credits.
• Radiopharmaceutical Manufacture, Production or Compounding, 10 Credits.
• Radiopharmaceutical Clinical Trials, 10 Credits.
• Regulation of Radiopharmaceuticals, 10 Credits.

1. Apply scientific knowledge in radiopharmacy services.
2. Promote safe handling of radiation sources and radiopharmaceuticals in compliance with relevant South African legislation.
3. Institute quality management in radiopharmacy according to current Good Radiopharmacy Practice (cGRPP) and in compliance with GMP in radiopharmaceutical production.
4. Produce, procure, distribute and dispose of radiopharmaceuticals according to cGRPP and in compliance with GMP in radiopharmaceutical production.
5. Compound and dispense radiopharmaceuticals, radiolabeled blood elements, biologicals and other novel radiopharmaceutical dosage forms according to GPP, cGRPP and recognised international standards and applicable legislation.
6. Conduct and monitor quality management for radiopharmaceuticals and instrumentation in the radiopharmacy.
7. Monitor and promote diagnostic accuracy and successful treatment outcomes as an active member of the nuclear medicine team.
8. Provide information and consultation on radiopharmaceuticals and Good Radiopharmacy Practice and in clinical trials.
9. Conduct research and prepare for publication in the field of radiopharmacy.

Associated Assessment Criteria for Exit Level Outcome 1

• Discuss the role of Radiopharmacy in Nuclear Medicine in diagnosis and therapy.

Associated Assessment Criteria for Exit Level Outcome 2

• Explain and apply legislation relevant to radiopharmacy services in the South African context.
• Discuss and implement local and international guidelines pertinent to production distribution and use and dispose of radionuclides and radiopharmaceutical products.
• Describe and demonstrate the principles of the "as low as reasonably achievable" (ALARA) concept and the importance of distance, shielding and time in radiation protection and radiation exposure limits.
• Demonstrate the practical implementation of radiation protection principles.

Associated Assessment Criteria for Exit Level Outcome 3

• Introduce and maintain a quality management system.
• Design and implement environmental requirements for a radiopharmacy, including choice, operation and maintenance requirements of laminar flow hoods and isolators.
• Undertake facility inspections and audits.
• Prepare, apply and monitor Standard Operating Procedures (SOPs) for radiopharmacy processes.
• Assure radiopharmacy equipment calibration and implement maintenance and cleaning programmes.
• Complete documents, maintain and review records by applicable legislation and SOPs.
• Discuss the role of international organisations in training and standards.
• Describe the GMP approach for radiopharmaceuticals and explain validation processes.

Associated Assessment Criteria for Exit Level Outcome 4

• Describe the legislative status of key radiopharmaceuticals and radionuclides.
• Explain and apply the production principles of radiopharmaceuticals in nuclear reactors, cyclotrons and generators.
• Order, receive, store and maintain the inventory of radiopharmaceuticals, ancillary drugs, supplies and related materials according to cGRPP.
• Distribute radiopharmaceuticals to the user according to cGRPP (packaging, labelling and transport).
• Conduct radionuclide and radiopharmaceutical waste management according to current South African legislation and cGRPP.
• Manage the ordering of and record-keeping for Section 21 radiopharmaceuticals.

Associated Assessment Criteria for Exit Level Outcome 5

• Compound radiopharmaceuticals, according to GPP and cGRPP. Perform generator elution, kit reconstitution, preparation of products not commercially available and other radiolabeling procedures.
• Dispense radiopharmaceuticals according to GPP and cGRPP, including evaluation of the prescription, preparation of bulk vials or individual patient doses for delivery to the user and prepare and reconstitute cold kits.
• Blood products: Prepare radiolabelled red and white cells and other blood elements according to local or ISORBE protocols.
• Compound, manipulate and prepare sterile admixtures according to SOPs, following aseptic techniques and principles of GMP or GPP.
• Appraise sterilisation methods for commonly used radiopharmaceuticals.
• Manage radiopharmacy cleaning programmes so that sources and reduce risks of microorganism contamination.
• Manage record systems for radiopharmaceutical preparations produced by legal requirements and organisational policies and procedures.

Associated Assessment Criteria for Exit Level Outcome 6

• Describe in detail the principles of radiopharmacy quality management in hospitals and production facilities.
• Conduct functional checks of instruments, equipment and devices.
• Determine radiopharmaceutical quality and purity requirements for radionuclidic, radiochemical and chemical purity.
• Evaluate particle size, sterility and pyrogenicity of radiopharmaceuticals.
• Ensure the completion and filing of appropriate records following cGRPP.

Associated Assessment Criteria for Exit Level Outcome 7

• Describe the pathophysiology of key disease states seen in nuclear medicine.
• Apply the principles of pharmaceutical care and patient monitoring.
• Interpret clinical laboratory results.
• Interpret laboratory tests associated with the identification and quantification of pathogens.
• Explain the mode of action of common radionuclides and radiopharmaceuticals.
• Analyse the rationale for the choice of specific radiopharmaceuticals in standard conditions (disease or suspected diagnosis, age and gender of the patient, contra-indications, radio-pharmaceutical availability and cost-containment issues).
• Evaluate patient preparation concerning prevention or recognition of drug or food interactions before radiopharmaceutical administration.
• Appraise the administration and clinical use of commonly used radionuclides and radio-pharmaceuticals.
• Demonstrate active participation in decision-making in the nuclear medicine team.

Associated Assessment Criteria for Exit Level Outcome 8

• Communicate radiopharmacy information (e.g. teaching, policies and procedures for the care of specific patients) to members of the healthcare team.
• Record, identify and address radiopharmaceutical causes of scintigraphic anomalies.
• Explain and demonstrate clinical trial methodology and Good Clinical Practice.

Associated Assessment Criteria for Exit Level Outcome 9

• Critically evaluate information sources, literature and research on medicines and practices in terms of evidence for decision-making and implementation in practice.
• Apply the principles of research methodology in the development of a research protocol. Obtain ethical clearance if necessary.
• Conduct research following established research methodology and ethics, as well as Good Clinical Practice where necessary.
• Analyse data, interpret findings or results and formulate conclusions and recommendations.
• Write and submit a technical report, manuscript for publication or minor dissertation and obtain approval.

Integrated Assessment

Assessment across the qualification forms an integral part of the teaching and learning process. In achieving the learning outcomes, learners are required to comply with the minimum assessments set for the level of the qualification, as per the Institution's Assessment Policy. Assessments vary depending on the module and the outcomes of the module; however, all modules are formatively and summatively assessed.

Formative and Summative Assessments

• Case study Presentation.
• Written paper.
• Assignment.
• Practical Log.
• Portfolio of evidence.
• Written tests.
• Written examination.
• Seminar presentation.
• Technical report.
• The manuscript for publication or minor dissertation based on the research outcomes.